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Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis

CompletedPhase 3

Sponsor: University Hospital, Bordeaux

Conditions: Multiple Sclerosis

Interventions: L-Carnitine, Placebo

Countries: France

The objective of this study is to evaluate the efficacy of L-carnitine versus placebo in the treatment of fatigue in multiple sclerosis patients. This study will randomize 60 patients in a cross-over design. This study is sponsored by academic French health institutions.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 18 years old and older
* Relapsing remitting (RR) secondary progressive (SP) or primary progressive multiple sclerosis according to McDonald 2005 (Polman) MS diagnostic criteria.
* Affected of fatigue for more than 3 months with global score on Modified Fatigue Impact Scale (MFIS)\>45.
* Indication of treatment of fatigue to the appreciation of the neurologist.
* Expanded Disability Status Scale (EDSS) not exceeding 6.0.
* Information and comprehensive agreement signed by patient and the investigator.
* Subject affiliated to health insurance coverage.

Exclusion Criteria:

* Patients with serious unstable disease :

  * recurrent or serious relapses
  * rapidly ongoing disability impairment in the preceding 6 months
  * serious or non stabilized depression
* Patients starting a new disease modifying therapy, immunosuppression or antidepressant therapy less than 3 months ago or not stabilized.
* Patients with a treatment of fatigue or of other condition that may interfere with fatigue evaluation to the appreciation of the neurologist.
* Energy drinks consumption or toxicomania.
* All other reasons to the opinion of the neurologist that may impair study management, especially patient compliance, neuro-psychological disorders that may input questionnaires filling.
* Person under protection of the law.
* Participation in other clinical trials (allowing for exceptions, after recommendation from the scientific council).

Locations (6)

Bordeaux, France
Fort de France, France
Limoges, France
Nancy, France
Nantes, France
Nice, France